19. Does DNA have to be collected on the first visit?
DNA can be collected at any visit, as this won’t change over time. All other samples are longitudinal (i.e., are expected to have changes over time). Therefore, DNA can be collected on any visit. This should be clarified in advance and coordinated with the NINDS Repository.
20. For sites that have already enrolled subjects, when should existing data be entered into ProFoRMS?
Once the site has access to the ProFoRMS module, data from already enrolled subjects should be entered within 30 days.
21. Will a site be able to download data collected in ProFoRMS?
This functionality is available through the Query Tool Module. Users can access data and sample information from their own site or other sites that have shared data.
22. How do I get permission to ProFoRMS?
Permission to ProFoRMS must be granted by a system administrator. You can make the request by following the steps below:
Login to the PDBP DMR
Select Account Management
Select Request Additional Privileges
Check the ProFoRMS box
Click Request Privileges
23. Why isn’t my form saving?
Validation check errors are reported at the top of the screen upon save. Scroll up and address any issues listed, such as incomplete required fields or entry that is out of acceptable bounds; then try saving again.
24. Why can’t I edit a form?
Forms can only be edited by the person to whom they are assigned. To reassign a form, the owner must perform the following steps:
Click on the form you wish to reassign
On the next screen, choose the username of the person to whom you wish to assign the form; then click Save to reassign the form
25. Why can’t I see the form I am attempting to collect data for?
Visit types are built into the system with required and optional forms associated with that visit. Check that you have selected the correct visit type or contact the Operations Team at PDBP-OPS@mail.nih.gov or call 301-402-6781 for further assistance.
26. What should I do if I can’t see a button that I need to perform an activity?
Each user is assigned to a customized permission group. It is possible you don’t have the permission to perform that action and the button is missing from your view. Contact the Operations Team at PDBP-OPS@mail.nih.gov or call 301-402-6781 to obtain a copy of the forms associated with each visit type.
27. Why is the GUID tool not generating a GUID?
The GUID tool works best with Java Runtime Environment 7 or higher. If possible, please upgrade your system and try again. If the issue persists, contact the Operations Team at PDBP-OPS@mail.nih.gov or call 301-402-6781.
28. Can I create customized forms in the DMR?
The PDBP DMR is not currently configured to allow the entry of custom forms. However, this functionality may be available in the future.
29. How can I try out the system without actually entering the data for my study?
There is a demo environment available for this exact purpose. Please contact the Operations Team at PDBP-OPS@mail.nih.gov or call 301-402-6781 to obtain access to this environment. Remember that data entered in the demo environment can be deleted at any time and cannot be transferred to your study.
30. What should I do if I’ve locked a form and I need to change data on it?
Administrators are the only users with the ability to change locked data. Contact the Operations Team at PDBP-OPS@mail.nih.gov or call 301-402-6781 for further assistance.
31. Will my password expire?
PDBP DMR passwords currently expire every 60 days according to NIH Security Policy. To prevent your account credentials from expiring, please reset your password at least once every 60 days. You cannot use a password that has been used within the past 25 changes.
To reset your password while your account is still active:
Login to the DMR
Select the Account Management module
Select Change Password from the left-hand navigation bar
Follow the steps listed
32. What should I do if my password is already expired?
To reset your password after your credentials have expired:
Navigate to the DMR.
Click on the “Forgot your password?” link near the top of the page.
You will receive an email with a link to change your password.
33. We are not currently a PDBP site or project. How can I collaborate with that group?
There is a one year embargo period beginning at the date of release of the notice of grant awards for the projects in the PDBP initiative. During this embargo period only PDPB investigators can access data across sites. Information about the individual PDBP projects is available at https://pdbp.ninds.nih.gov/projects-we-support.
34. My question is not answered here. What should I do?
Please contact the PDBP DMR Operations team at PDBP-OPS@mail.nih.gov or call 301- 402-6781 for further assistance. We will respond to your request within 24 hours.
The National Institute of Neurological Disorders and Stroke (NINDS) Parkinson's Disease Biomarkers Program (PDBP) was built to support new and existing research and resource development that promotes biomarker discovery for Parkinson's disease. In addition to supporting research projects, the PDBP provides a platform for researchers to deposit and access linked clinical and biological data on patients with Parkinson’s disease. It is anticipated that PDBP data will be used to develop biomarkers for diagnosis and/or disease progression that will ultimately be useful for treatment development.
17. What research is the PDBP supporting?
Currently, two types of research are being supported by the PDBP. The first type seeks to develop innovative new methods and tools for use in biomarker development, and the second type focuses on collecting subject data for use in developing a biomarker. Detailed information about our current research projects and contributors can be found at: Projects We Support.
18. What sorts of data are collected by the PDBP?
At this time, the PDBP is collecting extensive clinical information (e.g., MD-UPDRS, UPSIT, etc.), neuroimaging data (e.g., MRI, DTI, etc.), and biofluid data (e.g., CSF, plasma, serum for DNA/RNA, etc.). All data is being collected in accordance with the NINDS Common Data Elements and Human Genetics Repository criteria. Please see the following links for detailed information on data and protocols:
The goal of our current projects is to enroll slightly over eight hundred patients with Parkinson’s disease and about 500 unaffected control subjects. A small number of patients with Progressive Supranuclear Palsy, Multi-System Atrophy, and Alzheimer’s disease will also be enrolled. We anticipate that participant data from other NINDS-funded research will be added to the PDBP in the future.
20. Can I refer a patient for enrollment in the PDBP?
At this time, the only way for a subject to participate in the PDBP is to be enrolled in a PDBP-supported research project. Visit the PDBP Participants page and the Get Involved section to see projects that are actively enrolling study participants.
21. Can I obtain access to PDBP data?
As of November 2013, an up to twelve month embargo period for PDBP has been established. Generally, during this timeframe only PDPB investigators can publish on findings from analysis of PDBP data. However, it may be possible during this embargo period that some approved researchers with a valid institutional affiliation (academic and industry) outside of the PDBP consortium, and with a research request that addresses the goals of the PDBP, can request and receive access to both the clinical data and the biospecimens for analysis, as long as they agree to respect any specified embargo period. For more information on this policy, please see: Policy.
Summary data is available to all visitors to the PDBP website.
22. My question is not answered here. What should I do?
Please contact the PDBP DMR Operations team at PDBP-OPS@mail.nih.gov or call 301-402-6781 for further assistance. We will respond to your request within 24 hours
16. What is the purpose of the NINDS Parkinson’s Disease Biomarkers Program (PDBP)?
The NINDS PDBP is a study to identify biomarkers in Parkinson’s disease which will allow researchers to evaluate the progression of Parkinson’s disease in a more reliable, and faster way than is currently available. Currently, the only way to assess progression of Parkinson’s disease is on physical examination. Biomarkers are essential to develop better clinical trials and treatments which will slow the progression of Parkinson’s disease. That is, to develop treatments known as Neuroprotection treatments.
17. What is a biomarker?
A biomarker is a measurable characteristic associated with a disease state. For example, blood pressure can be considered a biomarker, in the broadest sense, of heart disease. No such markers exist for Parkinson’s disease, and there is a tremendous need for them in order to develop treatments which impact the actual biology of the disease. Right now, all we have are treatments that impact the symptoms.
18. How many people will participate in the NINDS Parkinson’s Disease Biomarkers Program (PDBP)?
Just over eight hundred people with Parkinson’s disease (PD) and almost five hundred people who are healthy controls will be participating. There will also be people participating with related disorders (including Progressive Supranuclear Palsy and Multiple System Atrophy). Also, samples and data from people who have PD and have participated in other studies will be included in this project. This is the largest Parkinson’s Disease Biomarkers project which the US Government has undertaken to date.
19. What procedures do Participants undergo?
Participants undergo a neurological exam (evaluation of their Parkinson’s disease as they would at a doctor’s visit), some paper and pencil testing (of the thinking, memory, mood, and thought processes), smell testing (a “scratch and sniff test”). In some parts of the study, they will also undergo brain imaging studies. They will donate biological samples including blood (like you would give at the doctor’s office), and cerebrospinal fluid (CSF) via lumbar puncture (LP). The entire visit will take most of the day.
20. What is a Lumbar Puncture (LP)? Is it safe?
A lumbar puncture, or spinal tap, is an outpatient (in the office) procedure. This allows a small amount of cerebrospinal fluid, the fluid which bathes the brain and spinal cord, to be collected. During the procedure, a small needle (a bit thicker than a human hair) is gently inserted into the back, after numbing medicine is injected into the skin and muscle tissue. Then the fluid is gently withdrawn. After that, the needle is withdrawn. It is a straightforward procedure with a low risk. Some people experience headache after the procedure. In order to reduce the risk of headache, a caffeinated beverage and increased fluid intake, as well as lying down as much as possible is often recommended. Your doctor will have specific advice regarding what you should do after a lumbar puncture. The entire procedure takes about half an hour.
Before you have a lumbar puncture, you must tell your doctor if you are on any blood thinning medications, including aspirin, and if you have ever had any problems with excessive bleeding. Also, let your doctor know if you are pregnant.
21. What is done with the information collected during the study?
The information collected in the study is given a unique identifier (i.e., a code) so that your name and identity are hidden to everyone but your doctor and their team. Then, this information is banked in the Data Management Resource (DMR) for the Parkinson’s Disease Biomarkers Program (PDBP). The biological specimens (blood samples, cerebrospinal fluid) are banked in a de-identified (anonymous) way at the National Institute of Neurological Disorders and Stroke (NINDS) Repository. The NINDS Repository has been in existence since 2001, and has banked samples from over 30 thousand people.
Investigators from academic institutions and industry (scientists) can submit a request to use the data and the samples for their research projects. They will have to write an application that is reviewed at the NIH and by experts, to assure that their project is feasible (possible) and likely to be of benefit to the discovery of biomarkers and treatments for Parkinson’s disease. People who use these data or samples will be required to share their data further with other researchers, and to let the DMR know what their results are. We plan to post these results so that participants and others can be made aware of them, on this public website.
22. Can I access the database?
Data access is currently not available to participants or the general public. However, summary data is available to the public through the Our Data page. Individuals who participated in one of the PDBP research projects will not be able to access their own individual data, because all data in the PDBP is anonymized. If you are a PDBP participant and you have questions about your test results, please discuss them with the investigator who is responsible for the study you participated in.
Yes, we welcome applications by investigators from academia and industry from US and non-US institutions.
19. What if I’m only interested in the clinical assessments and biological data available for biosamples?
Please find study-specific instructions for accessing clinical and biologic data from the cohorts available through the Biosample Resource Allocation Committee (BRAC) below:
The best way to access the clinical and biological data available for PDBP biosamples to is request an account with the PDBP data management resource (DMR), as described here.
MJFF cohorts: To register for access to the LRRK2 Cohort Consortium database, click here.To register for access to the BioFIND database, click here. DATATOP clinical data are available through the NINDS archives. 24-Hour Biofluid Sampling Study data are currently only released to individuals who are approved to access samples from this resource. For further details on available MJFF data resources, click here.
20. What is the process for applying for biosample access?
We have outlined the general steps on how to apply here. First, we encourage you to learn about the different cohorts and the types of biosamples available through the different websites, as listed. We also recommend contacting staff to find out the availability of samples that fit your exclusion-inclusion criteria. Once you have determined whether the samples you need are available, your next step is to submit an online application. Your application will then be reviewed by the BRAC and will receive a decision of approved, to be approved upon satisfactory revision, or denied.
21. What is required in the online application?
Within the webform, applicants are required to upload these documents: a biosketch, Research Strategy (4 page limit), and a table summary of samples of Interest. The first page of the webform requires the investigator to fill in basic information (e.g. name, institution, address) and to upload the biosketch. The second page of the webform requires the investigator to upload the application files (Research Strategy and Table Summary) and to provide information about funding support for the study.
22. Who reviews the applications?
The Biosample Resource Access Committee (BRAC) reviews the applications for biosample access and its members are listed here. BRAC reviewers are required to avoid any real or perceived conflict of interest and subscribe to the ethical requirements as described within the Conflict of Interest document. The BRAC Review is coordinated by Christine Swanson-Fischer, Ph.D.
23. What are the deadlines for submission?
The Biosample Resource Access Committee (BRAC) meets at least 5 times a year. Specific submission time windows and review dates are listed here.
24. How long will it take to find out about approval for biosample access?
Investigators will be notified by email the outcome of the review (i.e. approve, approve upon revisions, or deny) within a week after the review meeting. Summary statements are released within 2-3 weeks after review. For applications that were ‘approved upon revision’, investigators will be notified about concerns that would need to be addressed before the application could move forward.
25. What are the criteria used by the BRAC for approval of a sample request?
Review priorities include the experimental rationale, feasibility/reproducibility of the assays, expertise of the investigator, availability of institutional resources to support the study, and the statistical analysis of the number of samples required for hypothesis testing:
The BRAC uses the following guide questions when considering a sample request:
Is there sufficient evidence supporting the likelihood of this study identifying novel biomarkers or of otherwise contributing important knowledge regarding disease etiology, pathogenesis, diagnosis, or treatment?
Is the project technically feasible and, if preliminary data is provided, does the assay/platform utilized provide robust and reproducible results?
Do the investigators sufficiently justify the use of the resources?
Do the investigators have the expertise, personnel, and institutional setting to achieve the goals of the proposal?
Is the number of samples requested reasonable and sufficiently powered to achieve statistical significance for hypothesis testing and to demonstrate conservation of the resource (i.e. are the number of samples requested sufficient but not in excess of what is needed)? The NINDS PDBP staff will provide information on available inventory.
26. What happens next when my application gets approved?
This depends whether the study has funding or not:
If the study has funding, the samples are distributed to the investigator following a virtual meeting to introduce the sample distribution process ("on-boarding") and after fulfillment by the investigator of the additional requirements specified by the selected repository (i.e. MTA, Data Use Agreement, fees, data analysis and sharing plan). Please note that, for MJFF cohorts, the investigator must also sign a contract with MJFF. For questions about the contract with MJFF, please contact email@example.com. The post-BRAC process for biosample distribution is outlined in these documents (PDBP, BioFIND). For questions, please contact Christine Swanson-Fischer, PhD.
If the investigator has yet to obtain funding for the study, the BRAC will issue a letter to the applicant documenting provisional access to the samples requested. This letter can be used to support an application for funding opportunities from the NIH or other organizations. Conditional approvals will be valid for a period of up to 9 months.
27. What should I do next if my application needs revision?
You will receive an email from the BRAC Coordinator summarizing the reviewers’ critiques about your application. You will need to address these critiques by email and your response will be sent back to the reviewers to be evaluated.
28. What should I do if my application is denied?
You are welcome to re-apply if you feel you will be able to adequately address the flaws identified in your summary statement.
29. Do you provide funding?
We do not provide funding. Also, samples are released only if the investigator has funding for the proposed study.
30. What if I do not currently have funding for biomarker research?
You can still apply for biosample access, especially if your upcoming grant application needs a letter of support documenting approval of access to biosamples if funded. Thus, if your application is approved by the PD BRAC, a provisional letter of approval will be provided for your grant application.
32. Are there any additional considerations once biosample access is approved by the BRAC?
Each cohort may have additional documentation requirements such as a Biospecimen Use Agreement, Data Use Agreement, and/or Publication Policy, which must be acknowledged and received before samples are sent to the requestor. Specific contact information for each cohort represented under the PD BRAC can be found at this website.
Note: One condition to receive BRAC approved biospecimens is the return of data to a database associated with each PD cohort (i.e. DMR for PDBP, and LONI for BioFIND). There is an embargo period associated with each database, allowing time for investigators to publish their data before data is made available to the scientific community. Data from use of BioFIND and LRRK2 Cohort Consortium samples will be added to the public databases after a 90- and 45-day sequester period, respectively.
33. What happens during the on-boarding process?
Within 7 days after demonstration of funding and formal BRAC approval, the investigator will be contacted by the Post-BRAC coordinator, Christine Swanson-Fischer, PhD, to schedule an on-boarding webinar teleconference with NINDS, BioSEND, DMR (for PDBP cohort), MJFF (for LRRK2 Cohort Consortium, BioFIND, DATATOP, and 24-Hour Biofluid Sampling Study), and Harvard Biomarker Study Staff (for HBS cohort). This introductory call will review the process for distributing biosamples to the investigator such as:
Material Transfer Agreement (MTA)
Any balancing requirements for assay
Blinded sample distribution
Distribution of reference pool biosamples for quality control
Return of data and methods documentation
34. What are reference pools?
Biospecimen reference pools from the PDBP (CSF, plasma, serum) and BioFIND cohorts (plasma and CSF) are generated from residual volume. The goal is to provide researchers access to shared reference samples that can be used for normalization and standardization across sites, platforms and assays. A description of available reference pools is available here.
35. I have questions that were not addressed. Who do I contact?